FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

No Informed Consent in Alembic Trial

[ Price : $8.95]

FDA warns Indias Alembic Research Center that it failed to obtain informed consent for an in vivo bioequivalence study.

Acadia Gets Fast Track for Alzheimers Psychosis Drug

[ Price : $8.95]

FDA awards Acadia Pharmaceuticals a Fast Track designation for remlifanserin, an investigational, highly selective, 5-HT2A recepto...

Make Better Use of 505(b)(2) Pathway: Column

[ Price : $8.95]

Two InnoDev Partners consultants urge industry to re-embrace the 505(b)(2) approval pathway in instances in which it can save drug...

FDA Reform Requires a Whole-of-System Strategy: Editorial

[ Price : $8.95]

A Cureus Journal of Medical Science open-source editorial calls for a rebuilding of the U.S. scientific infrastructure as the only...

House Passes FDA Modernization Act 3.0 for Reducing Animal Testing

[ Price : $8.95]

The U.S. House of Representatives passes the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to a...

FDA, DoJ Expanding Enforcement Across Healthcare Ecosystem, Attorney Says

[ Price : $8.95]

In a mid-year enforcement update, Arnold Golden Gregory partner Gabriel Scannapieco says FDA and the Department of Justice are inc...

Opinion Piece Praises Diamantas' Vision for FDA Modernization

[ Price : $8.95]

A 7/20 opinion article contends that FDA acting commissioner Kyle Diamantas has outlined a broad vision for modernizing FDA by emp...

FDA Issues Early Alert on Baxter IV Administration Sets

[ Price : $8.95]

FDA issues an Early Alert warning healthcare providers about a potentially high-risk issue involving certain Baxter Duo-Vent solut...

China Surpasses U.S. in Novel Cancer Drug Approvals Since 2023: Analysis

[ Price : $8.95]

China approves more novel oncology drugs than the U.S. between 2020 and 2025, with its annual approval totals surpassing FDAs begi...

Dyne Therapeutics BLA for Duchenne Muscular Dystrophy

[ Price : $8.95]

FDA accepts for priority review a Dyne Therapeutics BLA for zeleciment rostudirsen for treating individuals with Duchenne muscular...